Drug-coated balloon catheters for body lumens

Abstract

Various embodiments disclosed relate to drug-coated balloon catheters for treating, preventing, or reducing the recurrence of a stricture and/or cancer, or for treating benign prostatic hyperplasia (BPH), in a non-vascular body lumen and methods of using the same. A drug-coated balloon catheter for delivering a therapeutic agent to a target site of a body lumen stricture includes an elongated balloon having a main diameter. The balloon catheter includes a coating layer overlying an exterior surface of the balloon. The coating layer includes one or more water-soluble additives and an initial drug load of a therapeutic agent. In some embodiments, the balloon catheter includes a length-control mechanism which stretches and elongates the balloon when it is in a deflated state, giving the balloon a smaller cross-sectional deflated profile for tracking through the body lumen and for removal after treatment.

What is claimed is: 
     
       1. A drug-coated balloon catheter comprising:
 an elongated balloon; and 
 a coating layer overlaying an exterior surface of the balloon, the coating layer comprising an initial drug load of a therapeutic agent comprising paclitaxel, and
 at least one additive comprising a sugar derivative, a chemical compound with one or more ester moieties, or a combination thereof; 
 
 wherein the coating layer directly contacts the exterior surface of the balloon; and 
 wherein a soaking procedure for treating a target site in a body lumen with the drug-coated balloon catheter is sufficient for the coating layer to release 37 wt % to 97 wt % of the initial drug load of the therapeutic agent from the coating layer, wherein the soaking procedure consists of
 passing the drug-coated balloon catheter through an introducer sheath into a cylindrical vessel, the cylindrical vessel comprising 0.9% saline at 37° C., 
 soaking the drug-coated balloon catheter in the saline in the cylindrical vessel for 1 minute, 
 inflating the drug-coated balloon catheter for 1 minute, and 
 withdrawing the drug-coated balloon catheter from the cylinder. 
 
 
     
     
       2. The drug-coated balloon of  claim 1 , wherein the at least one additive comprises the sugar derivative. 
     
     
       3. The drug-coated balloon of  claim 1 , wherein the at least one additive comprises the chemical compound with one or more ester moieties. 
     
     
       4. The drug-coated balloon catheter of  claim 1 , wherein the elongated balloon has a length of 20 mm to 160 mm. 
     
     
       5. The drug-coated balloon catheter of  claim 1 , wherein the coating layer has a weight ratio of the therapeutic agent to the one or more additives of 0.05:1 to 20:1. 
     
     
       6. A drug-coated balloon catheter comprising:
 an elongated balloon; and 
 a coating layer overlaying an exterior surface of the balloon, the coating layer comprising
 an initial drug load of a therapeutic agent comprising paclitaxel, and 
 at least one additive comprising a sugar derivative, a chemical compound with one or more ester moieties, or a combination thereof; 
 
 wherein the coating layer directly contacts the exterior surface of the balloon; and 
 wherein flushing a target site in a body lumen and holding the drug-coated balloon catheter in position at the target site to hydrate the coating layer is sufficient for the body lumen tissue at the target site to have a concentration of the therapeutic agent of 0.083 μg/g to 582 μg/g at 1 day. 
 
     
     
       7. The drug-coated balloon catheter of  claim 6 , wherein the treatment procedure is sufficient for the coating layer to release the therapeutic agent from the coating layer into body lumen tissue at the target site such that the body lumen tissue at the target site has a concentration of the therapeutic agent of 0.003 μg/g to 62 μg/g at 7 days. 
     
     
       8. The drug-coated balloon catheter of  claim 6 , wherein the treatment procedure is sufficient for the coating layer to release the therapeutic agent from the coating layer into body lumen tissue at the target site such that the body lumen tissue at the target site has a concentration of the therapeutic agent of 0.025 μg/g to 33 μg/g at 28 days. 
     
     
       9. The drug-coated balloon catheter of  claim 6 , wherein the initial drug load of the therapeutic agent is from 1 microgram to 20 micrograms per square millimeter of the balloon at the nominal diameter of the balloon. 
     
     
       10. The drug-coated balloon of  claim 6 , wherein the at least one additive comprises the sugar derivative. 
     
     
       11. The drug-coated balloon of  claim 6 , wherein the at least one additive comprises the chemical compound with one or more ester moieties. 
     
     
       12. The drug-coated balloon catheter of  claim 6 , wherein the elongated balloon has a length of 20 mm to 160 mm. 
     
     
       13. A drug-coated balloon catheter comprising:
 an elongated balloon; and 
 a coating layer overlaying an exterior surface of the balloon, the coating layer comprising
 an initial drug load of a therapeutic agent comprising paclitaxel, and 
 at least one additive comprising a sugar derivative, a chemical compound with one or more ester moieties, or a combination thereof, 
 
 wherein the coating layer directly contacts the exterior surface of the balloon; and 
 wherein flushing a target site in a body lumen and holding the drug-coated balloon catheter in position at the target site to hydrate the coating layer is sufficient for the coating layer to release more than 30 wt % of the initial drug load of the therapeutic agent from the coating layer to the target site in the body lumen. 
 
     
     
       14. The drug-coated balloon of  claim 13 , wherein the at least one additive comprises the sugar derivative. 
     
     
       15. The drug-coated balloon of  claim 13 , wherein the at least one additive comprises the chemical compound with one or more ester moieties. 
     
     
       16. The drug-coated balloon catheter of  claim 13 , wherein the elongated balloon has a length of 20 mm to 160 mm. 
     
     
       17. A drug-coated balloon catheter comprising:
 an elongated balloon; and 
 a coating layer overlaying an exterior surface of the balloon, the coating layer comprising
 an initial drug load of a therapeutic agent comprising paclitaxel, and 
 at least one additive comprising a sugar derivative, a chemical compound with one or more ester moieties, or a combination thereof; 
 
 wherein the coating layer directly contacts the exterior surface of the balloon; and 
 wherein flushing a target site in a body lumen and holding the drug-coated balloon catheter in position at the target site to hydrate the coating layer is sufficient for the coating layer to release 0.1% to 25% of the initial drug load of the therapeutic agent from the coating layer to a body lumen wall at the target site in the body lumen. 
 
     
     
       18. The drug-coated balloon of  claim 17 , wherein the at least one additive comprises the sugar derivative. 
     
     
       19. The drug-coated balloon of  claim 17 , wherein the at least one additive comprises the chemical compound with one or more ester moieties. 
     
     
       20. The drug-coated balloon catheter of  claim 17 , wherein the elongated balloon has a length of 20 mm to 160 mm.